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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR
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CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N8378
Medical Device Problem Code Disconnection (1171)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/31/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a clearlink system non-dehp catheter extension set detached between the luer lock adapter and line.This issue was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye which revealed that two piece luer lock assembly and the tubing was separated.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK LUER ACTIVATED VALVE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12519507
Report Number1416980-2021-05879
Device Sequence Number17201575
Product Code FPA
UDI-Device Identifier00085412048918
UDI-Public(01)00085412048918
Combination Product (Y/N)Y
Initial Reporter CountryNZ
PMA/510(K) Number
K112893
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Catalogue Number2N8378
Device Lot NumberUR21D13067
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/31/2021
Supplement Date Received by Manufacturer10/22/2021
Initial Report FDA Received Date09/23/2021
Supplement Report FDA Received Date10/26/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/14/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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